FDA Medical devices recall ·
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software… recall
- Recall number
- Z-0348-2025
- Date
- (initiated October 2, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Why was it recalled?
The door on the Spectrum IQ Infusion pump may not be able to fully close.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
Distribution
GA, ID
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0348-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.